BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C4D (SP91)

    MDR report key: 7974880 · Received October 17, 2018

    Report

    Report Number
    1649339-2018-00007
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 13, 2018
    Manufacturer
    CELL MARQUE CORPORATION
    Product Code
    NJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT THAT NO ADDITIONAL INFORMATION OR MEDICAL ISSUES HAVE BEEN REPORTED TO CELL MARQUE CORPORATION FOR THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CALL WAS RECEIVED FROM THE UNIVERSITY (B)(6) DIRECTOR OF OCCUPATIONAL MEDICINE DR. (B)(6). SHE CALLED TO REPORT THAT SEVEN PATIENTS (6 FEMALES AND 1 MALE) AND EMPLOYEES OF THE HOSPITAL, CAME IN TO HAVE AN ANNUAL TB SCREENING. ALL SEVEN PATIENTS WERE INJECTED WITH C4D (SP91) RABBIT POLYCLONAL ANTIBODY, PREDILUTE IN A LEICA BOND DISPENSER. THE NURSE PRACTITIONER ASSUMED SHE WAS INJECTING TUBERCULIN PURIFIED PROTEIN DERIVATIVE ALSO KNOW AS TUBERSOL USED IN THE TESTING FOR TB. POST INJECTION SIX OF THE PATIENTS EXPERIENCED THE FOLLOWING PHYSIOLOGICAL SYMPTOMS: FIVE OF THE SEVEN PATIENTS EXPERIENCE HEADACHES. TWO PATIENTS HAD AN ALLERGIC REACTION. ONE OF THE TWO PATIENTS EXPERIENCED A DELAYED HEADACHE AND DEVELOPED A RASH. THE PERSON WITH THE DELAYED REACTION HAD A SEVERE HEADACHE WITH JOINT PAIN AT THE INJECTION SITE. THE PATIENT WAS GIVEN A STEROID AND A ANTIHISTAMINE AS WELL AS A CT SCAN. THE ERROR WAS DISCOVERED WITHIN 2 HOURS OF INJECTION. AT THE TREATING PHYSICIAN'S REQUEST AND ADVICE OF THE EH&S OFFICER, THE SAFETY DATA SHEET (SDS) DOCUMENTS FOR THE ANTIBODY, SODIUM AZIDE AND BOVINE SERUM WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816954 C4D (SP91) RABBIT MONOCLONAL PRIMARY ANTIBODY NJT CELL MARQUE CORPORATION PA0792 52743

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention